Powertoothbrushing for Treating Gingivitis
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53233
- Marquette University School of Dentistry
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
A subject who meets all the following criteria will be eligible to enroll in this study.
- Age range 18 - 65 years
- Routine manual toothbrush user
- A Subject who agrees to use the assigned toothbrush as the only cleaning device for the study duration, refraining from daily interdental cleaning and/ or antiseptic mouthrinsing.
- Mild to moderate gingivitis as measured by A. Modified Gingival Index (MGI) average score of at least 1.2, and / or B. Bleeding on Probing (BOP) of at least 20% of all sites but not more than 50% of sites.
- Probing Pocket Depth (PPD) of 4 mm or lower
- At least 20 natural teeth - scoreable (crowns or bridgework are non-scoreable).
Exclusion Criteria:
Any subject meeting one of the following criteria will not be included in the study.
- Daily user of interdental cleaning devices, such as floss, floss picks, toothpicks, interdental brush, water flossing device
- Regular user of antimicrobial mouthrinses within one week of entry into study
- Professional prophylaxis within one month of entry into the study
- Use of antibiotics within one month prior to the baseline exam
- Signs of moderate to severe periodontitis or caries, categorized as PPD of 5 mm of higher and attachment loss of 3 mm or higher
- Subjects with orthodontic bands and/or dental appliances.
- Participated in an oral care related study in the last 90 days prior to this study
- Pregnant or lactating women
- Patients with a history of significant cardiovascular disease, diabetes, cancer, AIDS, or other organ impairment that would preclude their participation in the study
- Acute/concurrent illness such as hepatitis, herpes simplex infections, influenza, etc.
- History of rheumatic fever, cardiovascular valvular disease, artificial joint replacement or kidney or liver disorders
- Chronic use of steroids; limited use of NSAID's (≤ 325 mg/day)
- Current Smoker (within the last 3 months)
- Other medical or dental conditions that would affect the study
- Inability to commit to all necessary study visits from baseline to 12 weeks
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Powered toothbrush intervention
Subjects will be provided an oscillating rotating powered toothbrush as the experimental intervention, and given written instructions on its proper use.
Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks.
Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study.
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a battery powered oscillating rotating toothbrush will be used for twice daily regular home dental hygiene
다른 이름들:
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간섭 없음: Manual toothbrush
Subjects will be provided a manual toothbrush as the control group and given written instructions on its proper use.
Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks.
Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Gingivitis
기간: 12 weeks post-baseline
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Baseline and 12 weeks post-baseline measures. Proportion of bleeding sites per patient was used as Full mouth BOP Score. The score for each site was either 1 for bleeding and 0 for no bleeding. Following is the full description of each outcome measure reported in the protocol. The Modified Gingival Index3 (MGI) will be measured on six sites - mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual - of all teeth using a 0-4 scale. Lower score no inflamation and higher severe inflammation. Dental plaque will be evaluated using the Lobene modification4 of the Turesky modification of the Quigley-Hein Plaque Index (PI)5. The score 0 to 5. Lower score means no plaque and higher score increasing plaque.Full-mouth Probing Pocket Depth (PPD) will be measured on the six locations of each tooth (mesial-buccal, buccal, distal-buccal, mesial-lingual, lingual, distal-lingual) using a periodontal probe. |
12 weeks post-baseline
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공동 작업자 및 조사자
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .